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Completed

NCT Number: NCT00175240

Enhancing the Secondary Prevention of Coronary Artery Disease

People with coronary artery disease can reduce their chance of having a heart attack by making healthy lifestyle choices (diet, exercise, quitting smoking,etc.). There are also many medications that have been proven to reduce the risk of heart attacks and may even help people live longer. This study will look at different ways of improving the use of these beneficial medications to enhance the quality of care for people with this condition.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Alberta Hospital; Royal Alexandra Hospital, Foothills Medical Centre (Calgary)

Edmonton, Alberta, T6G 2B7, Canada

About this study

BACKGROUND: Despite the abundant evidence base for secondary prevention, practice audits consistently demonstrate substantial "care gaps" between this evidence and clinical reality such that many patients with Coronary Artery Disease (CAD) are not offered all possible therapies for the prevention of myocardial infarction or death. For example, even after an acute myocardial infarction, almost one fifth of patients continue to smoke; over half with hypertension or hyperlipidemia have poorly controlled pressure or lipid levels; and proven therapies such as statins, ACE inhibitors, beta-blockers and antiplatelet agents are under-prescribed.

Multiple barriers are often responsible for the lack of implementation of proven efficacious therapies and traditional means of educating practitioners (journal articles, CME, conferences, etc) are usually ineffective in altering practice. Clearly novel interventions to improve the quality of prescribing are needed. Local opinion leaders are trusted by their peers to evaluate medical innovations and thus influence practice patterns within their community. Few controlled studies, however, have evaluated their effect on changing prescribing practices for common conditions such as CAD.

HYPOTHESIS: This trial will test 2 quality improvement interventions. The principle hypothesis is: does a one-page evidence summary endorsed by local opinion leaders increase the provision of secondary prevention therapies in patients with CAD compared to usual care? The secondary hypotheses are: does the same intervention but without local opinion leader endorsement improve the provision of secondary prevention strategies in patients with CAD compared to usual care? Does local opinion leader endorsement increase the effectiveness of the quality improvement intervention?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Alberta residents who undergo a cardiac catheterization and are diagnosed with coronary artery disease (> or equal to 50% stenosis in at least one vessel).

Exclusion criteria

  • no fasting lipid panel within the previous 6 weeks
  • on a statin at maximal dose
  • on a statin/lipid lowering drug and LDL-C is 2.5 mmol/L or less (prior to Sept 2006) and LDL-C is 2.0 mmol/L or less (after Sept 2006)
  • not on a statin and LDL-C is 1.8 mmol/L or less
  • acute myocardial infarction or cardiogenic shock
  • require emergency bypass surgery following catheterization
  • contraindication to statins (e.g. cirrhosis, inflammatory muscle disease)

Treatment and study plan

Evidence summaries endorsed by local opinion leaders

Behavioral

Primary outcomes

  1. Composite measure representing improvement in cholesterol-related secondary prevention consisting of (1) provision of a statin sample (2) provision of a statin prescription or (3) dosage increase of a statin within the first 6 months post-angiogram.

Secondary outcomes

  1. Provision of other proven efficacious medications for coronary artery disease by 6 months including ACE inhibitors, beta-blockers and antiplatelet agents.

  2. Changes in the provision of other lipid lowering medications.

  3. Smoking rates - receipt of smoking cessation advice/nicotine replacement products/bupropion.

  4. Repeat fasting lipid panel within 6 months post-angiogram.

  5. Proportion of patients achieving target LDL-C of 2.0mmol/l or less.

  6. Clinical events including myocardial infarction, stroke, admissions for coronary artery disease, total hospitalizations and mortality.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • Alberta Heritage Foundation for Medical Research
  • Heart and Stroke Foundation of Canada
  • Pfizer

Registry information

Official study title

Enhancing the Use of Secondary Prevention Strategies in Patients With Coronary Artery Disease (The ESP-CAD Study)

Important dates

Study start
2005
Primary completion
2011
Study completion
2015
First posted
Sep 15, 2005
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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